Our team comprising CRAs with comprehensive understanding of sites and experience across full study life-cycle facilitate site management, work closely with your study teams assuring quality study data. At AU3M, experienced CRAs perform on-site as well as remote site monitoring and leverage various tools to conduct remote site management activities.

From monitoring clinical study sites remotely to ensuring clinical trials are organized, recorded as well as reported in sync with protocols, ICH GCP, SOPs and other requisite regulatory requirement, we provide the whole gamut of remote CRA services. With our CRAs accelerating progress by tracking regulatory submissions, data query resolution and CRF completion, we ensure that our clients’ clinical research programs achieve successful results in terms of excellence and quality.

Our remote CRA services include activities detailed below.

• 01 Create and prepare trial protocols
• 02 Liaise to identify, evaluate, and establish trial sites
• 03 Conduct site visits encompassing monitoring, initiation, site qualifications and management, as well as close-out visits
• 04 Assure correctness, validity, and completeness of clinical data at assigned sites in sync with client requirements and protocols
• 05 Facilitate remote CRA by monitoring to assure data integrity as well as patient safety syncing with specific regulations
• 06 Monitor quality pertaining to clinical deliverables and assure quality issues are addressed
• 07 Ensure protocols are executed in accordance with the required regulatory requirements such as IRB/EC and GCP/ISO, as well as BD-established standards
• 08 Review protocol deviations
• 09 Ensure delivery of timely, quality monitoring reports

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Clinical Trial Project Management
Successful clinical trials revolve around robust clinical trial project management. AU3M provides clinical trial project management services to deliver Phase I to Phase IV clinical trials right on time and well within budget. At AU3M, study managers and project managers monitor every aspect of clinical trials, ensure successful execution of your project meeting the required quality standards. Our clients rest faith on our Project Management expertise to capture critical data supporting project/study goals entwined with medical and clinical integrity.

Our clinical trial project managers and study managers have rich experience in managing clinical trials across Phase I to Phase IV and in achieving successful completion of our clients’ project or study. As proactive and strategic thinkers, clinical trial project managers demonstrate project ownership and management, monitor your project timeline, execute risk mitigation and overcome obstacles to ensure successful outcomes of your clinical trials. Our project managers execute the clinical programs starting from protocol design until the execution of final clinical project report.

With our project managers serving as the primary contact for our clients’ clinical trials, we keep all channels open to ensure strong communication. Our clinical trial project managers also maintain up-to-date timelines starting from the client project/study initiation and track timelines for successful completion. As part of robust Project Management, we ensure selection of qualified sites, facilitate study training, monitoring, data verification, status tracking, risk management as well as contingency plans, and project/study close-out.

Special features of our clinical trial project management activities include:

• 01 Develop project management plans encompassing training, communication, risk mitigation and escalation procedures
• 02 Enable site qualification as well as selection
• 03 Provide consulting around clinical development programs
• 04 Facilitate protocol writing and study design
• 05 Prepare risk assessment plans and feasibility studies
• 06 Generate project materials including protocol and CRFs
• 07 Facilitate necessary documentation
• 08 Develop and monitor timelines
• 09Enable proactive risk identification, evaluation as well as mitigation
• 10Integrate QC and maintenance into the project
• 11Closure of trials which includes site closeout